Import pre-authorisation for trusted firms frees up resources to tackle purity problems
The US Food and Drug Administration (FDA) has named 13 companies that will be allowed to import drug products into the US with reduced scrutiny. Each company will be permitted to import up to five products under expedited entry arrangements for a period of two years.
The FDA’s Secure Supply Chain Pilot Program is an effort to free up the agency’s resources to focus on areas where imports pose the greatest risk to patients and consumers. The scheme rewards manufacturers for voluntarily adopting best practice and integrating integrity and security into their supply chain operations.
The move comes in the wake of a string of product recalls and import bans as some elements of the pharma industry struggle to maintain appropriate quality standards.
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